Inspection Readiness for GCP – Supporting Third-Party Inspections

ForgeFlow Analytics, a Third-Party Data Processing Vendor used by a Sponsor company for a clinical trial, has been notified that it will be inspected by a regulatory agency. This is ForgeFlow’s first GCP inspection, and they’re unsure how best to prepare. Luckily, the Sponsor company is ready to support them and collaborate on developing a comprehensive plan to light the way. We’ll follow both companies, pointing out essential strategies as they navigate the intense scrutiny of an inspection and transform potential challenges into opportunities for strengthening partnerships. Ultimately, you’ll be equipped with the knowledge and best practices needed to foster robust collaborations, streamline inspection processes, and significantly increase the likelihood of successful regulatory outcomes for your drug development programs.